Indonesia OKs 'private research' of COVID-19 vaccine after barring Phase II trial

JAKARTA (Reuters) – Indonesia has approved private research of COVID-19 vaccine candidate Nusantara that is backed by a former health minister, after recently saying a mid-stage trial for it could not proceed amid safety and data integrity issues.

Just this month, Indonesia’s drug and food agency (BPOM) said approval for a Phase II trial for the vaccine, developed by local firm PT Rama Emerald Multi Sukses and America’s Aivita Biomedical, would not be granted as its sponsors had failed to fulfil Phase I clinical trial requirements.

The nod for private research comes amid mounting political pressure to approve the trial for the vaccine, which is backed by former minister Terawan Agus Putranto who enjoys the support of some in Indonesia’s political and military elite.

Some parliamentarians have even volunteered to provide blood samples and participate in the study in a show of support.

But Indonesian scientists and public health experts are worried this sets a wrong precedent for global pharmaceutical firms looking for opportunities to fast track their drugs.

“Indonesia aspires to be a hub for innovation, including in the biomedical space, but for it to be taken seriously, it needs to establish a conducive ecosystem,” said Ines Atmosukarto, a molecular biologist who works on vaccine development.

Terawan, who initially downplayed the seriousness of the COVID-19 pandemic before being replaced in December, was not immediately available for comment. Rama Emerald Multi Sukses and Aivita were also not available to comment.

The Nusantara vaccine uses a dendritic cell method commonly used in research for cancer treatment and is built upon immune cells drawn from patients’ blood.

BPOM chief Penny Lukito told Reuters that a memorandum of understanding (MOU) was signed on Monday by the health minister, the drug regulator and the military chief of staff to allow the private research into the vaccine to be conducted at the Gatot Subroto Army Hospital in Jakarta.

“The clinical trial was converted to a research-based service that is regulated and supervised by the health ministry. So the product cannot be registered as a mass vaccine,” the BPOM chief added.

Neither the agency nor the health ministry could immediately clarify the scope of permissible research, or whether it would include continued human trials.

Jonny, a military doctor on the vaccine development team who goes by one name like many Indonesians, said he had not received official notification of the MOU and was unable to comment.

A Phase I trial of the vaccine, which was conducted in Java in December, showed that 70% of its 28 participants suffered adverse side effects including several cases of hypernatremia, increased blood urea nitrogen and increased cholesterol, according to BPOM.

It also identified issues with lab practices and data inconsistencies in the trial, leading it to decide against approving the Phase II trial.

“There seems to be no punishment for parties that do not behave ethically, and don’t follow internationally accepted guidelines for clinical research with public funding,” the molecular biologist Atmosukarto noted.

Indonesia is grappling with the worst COVID-19 outbreak in Southeast Asia, having reported over 1.61 million infections and more than 43,000 deaths.

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